Clinical trial · Interventional
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a new surgical procedure that induces rapid liver regeneration in patients with small liver remnant planning for major liver resection. It is a two-staged operation with stage I including portal vein ligation and splitting the right liver away from the left liver. After stage I, the left liver will undergo rapid liver regeneration and the stage II operation can be performed at 7-10 days after stage I operation when the liver remnant reaches an adequate size. In stage II operation, the right liver that contains the tumor is then removed. This surgical procedure was incepted in Germany in 2013 and was later started in Queen Mary Hospital in Hong Kong for the first time in December 2015. The initial indication was mainly for colorectal liver metastasis but due to the relatively high incidence of hepatocellular carcinoma in Hong Kong, HBP surgery team of Queen Mary Hospital has transferred this procedure to be applied for hepatitis-related hepatocellular carcinoma and so far, the centre has cumulated one of the largest single-center experience in the literature. Nonetheless, the usual approach for ALPPS involved open surgery and induced substantial surgical stress to the patient, especially after stage I operation. With the advent of minimally invasive liver surgery in recent years, the team has successfully applied laparoscopic surgery to ALPPS in 2019. Despite the advancement in laparoscopic surgical skills that rendered laparoscopic ALPPS feasible, there is scarcity of data in the literature to evaluate its outcome in comparison with open ALPPS with regard to perioperative recovery and liver regeneration. Hence, the aim of this project is to evaluate the short-term clinical outcomes of laparoscopic ALPPS and the impact of laparoscopy on liver remnant regeneration after ALPPS in a prospective randomised clinical trial setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic ALPPS
- description
- Laparoscopic ALPPS procedure
- interventionNames
- Procedure: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)
- type
- ACTIVE_COMPARATOR
- label
- Open ALPPS
- description
- Open ALPPS procedure
- interventionNames
- Procedure: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)
Primary outcomes (1)
- measure
- Amount of future liver remnant volume increment by percentage after stage I ALPPS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a diagnosis of malignant liver tumor contemplating for extended right hepatectomy or right trisectionectomy 2. Patient consent 3. Age \>/= 18 4. FLR/ESLV \</= 30% 5. Indocyanine green clearance rate at 15 mins : \< 18% 6. Platelet count \> 100x10\^9/L 7. Child A cirrhosis (due to hepatitis B/C virus, or alcohol, or autoimmune disease) 8. American Society of Anaesthesiology score \< 3 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Technical factors eligible for laparoscopic ALPPS * single long-segment portal Exclusion Criteria: 1. Absence of consent 2. Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy 3. ECOG performance status \>/= 3 4. Main portal vein thrombosis 5. FLR/ESLV \> 30% Technical factors not eligible for laparoscopic ALPPS * Short-segment right portal vein or early bifurcation of right anterior/posterior portal vein, or other portal vein anomalies * Large tumor size with diameter \> 5 cm * Intolerance to CO2 pneumoperitoneum
References
Publications (11)
- BACKGROUNDLang H, de Santibanes E, Schlitt HJ, Malago M, van Gulik T, Machado MA, Jovine E, Heinrich S, Ettorre GM, Chan A, Hernandez-Alejandro R, Robles Campos R, Sandstrom P, Linecker M, Clavien PA. 10th Anniversary of ALPPS-Lessons Learned and quo Vadis. Ann Surg. 2019 Jan;269(1):114-119. doi: 10.1097/SLA.0000000000002797. PMID 29727331
- RESULTSchnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5. PMID 22330038
- RESULTSchadde E, Ardiles V, Robles-Campos R, Malago M, Machado M, Hernandez-Alejandro R, Soubrane O, Schnitzbauer AA, Raptis D, Tschuor C, Petrowsky H, De Santibanes E, Clavien PA; ALPPS Registry Group. Early survival and safety of ALPPS: first report of the International ALPPS Registry. Ann Surg. 2014 Nov;260(5):829-36; discussion 836-8. doi: 10.1097/SLA.0000000000000947. PMID 25379854
- RESULTLinecker M, Bjornsson B, Stavrou GA, Oldhafer KJ, Lurje G, Neumann U, Adam R, Pruvot FR, Topp SA, Li J, Capobianco I, Nadalin S, Machado MA, Voskanyan S, Balci D, Hernandez-Alejandro R, Alvarez FA, De Santibanes E, Robles-Campos R, Malago M, de Oliveira ML, Lesurtel M, Clavien PA, Petrowsky H. Risk Adjustment in ALPPS Is Associated With a Dramatic Decrease in Early Mortality and Morbidity. Ann Surg. 2017 Nov;266(5):779-786. doi: 10.1097/SLA.0000000000002446. PMID 28806301
- RESULTChan AC, Pang R, Poon RT. Simplifying the ALPPS procedure by the anterior approach. Ann Surg. 2014 Aug;260(2):e3. doi: 10.1097/SLA.0000000000000736. No abstract available. PMID 24866543
- RESULTChan AC, Poon RT, Chan C, Lo CM. Safety of ALPPS Procedure by the Anterior Approach for Hepatocellular Carcinoma. Ann Surg. 2016 Feb;263(2):e14-6. doi: 10.1097/SLA.0000000000001272. No abstract available.